Senior Manager of Clinical Operations

Senior Manager of Clinical Operations

Office Based- Murray Hill, NJ

Overview: My client is an Oncology drug discovery and development company that is looking for a Senior Manager of Clinical Operations. This person will come in to manage phase 3 of a current project from start-up to close-out.

The Company: Founded in 2011, my client is an Oncology drug discovery company that is working towards the treatment of hematological cancers and solid tumors. They have raised $531 million since that time to advance their pipeline of programs. They specialize in proprietary antibody drug conjugates.

The Senior Manager will be responsible for: The start-up and executions of multiple clinical trials from start to finish. This will include oversight of all partners and vendors, budgets, timelines, status report, and risk and mitigation plans. 

• Coordinate all aspects of domestic and international clinical trials from start-up through close-out including; 
  • Study Development
  • Project Management 
  • Budgets and Timelines 
  • Resource Requirements 
  • Audit Readiness 
  • Corrective Action Plans 
  • Trial Risk
  • Operations

• Collaborate with independent clinical advisors during the development of clinical protocols.
• Lead study teams through the use of strong project management skills and cross functional team work
• Recruit, negotiate compensation, manage deliverables, and provide feedback to consultants and contractors.
• Manage site and investigator selection process.
• Develop/ review clinical project deliverables such as;
  •  Protocols and Amendments 
  • Case Report Forms (CRFs)
  • Investigator Brochures 
  • Informed Consent 
  • Trial Manuals 
  • Operation Plans and others 
• Work with data management to set up data capture system, capture ongoing data, and data review. 
• Manage clinical supply usage, enrollment of subjects, and regulatory document flow.
• Provide oversight of clinical trials to insure safety and compliance

Required Experience 

• BS/BA in related field 
• 4+ years of experience in clinical research 
• Knowledge of ICH and global clinical trails 
• Ability to manage multiple priorities across multiple trials 
• Experience with CRO and Vendor management 
• Experience leading cross functional studies and teams
• Willingness to travel up to 20%
• Oncology experience preferred 
• Excellent time management, planning, and prioritizing ability 
• Strong communication skills